Kornimate/medical-research-clean huggingface dataset:
serum level of calpains product as a novel biomarker of acute lung injury following cardiopulmonary bypass

Conditions: Lung Injury, Acute

Summary: more than 2 million patients worldwide receive heart surgery every year, majority of these surgical patients will undergo cardiopulmonary bypass. however, the incidence of postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%. according to clinical experience, the earlier lung damage is detected, the more successful the treatment will be. on the basis of traditional detection, the investigators found a new indicator, serum calpains, which are easy to obtain and have certain specificity. importantly, they can predict postoperative acute lung injury within 1 hour after cardiac surgery. it is meaningful that this indicator can provide clinicians with early decision-making advice and immediate treatment for patients who may be at risk.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * underwent cardiac surgery using cpb technology. exclusion criteria : * patient's lack of consent to participate; * presence of abnormal liver, kidney or other organ function; * pulmonary inflammation, chronic obstructive pulmonary disease or tumors; * underwent cardiac surgery without cpb technology; * postoperative need for extracorporeal membrane oxygenation support.

Keywords: cardiopulmonary bypass calpain lung injury
psychometric properties upper limb function measures multiple sclerosis

Conditions: Multiple Sclerosis

Summary: current study will investigate de quality (psychometric properties) and clinical utility of several measures of upper limb function, according to disability level. therefore, several aspects will be inquired: * was there an effect of rehabilitation * is the measure able to detect change over time? and thus the change exceed measurement error and is it clinically important (responsiveness) * does the measure assess what it claims to measure (validity) * is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects) * does the measure gives similar results under consistent test conditions on another testing day (reliability) worldwide, theoretical approaches to physical therapy and rehabilitation in multiple sclerosis often appear significantly different. since the present research protocol will be performed at different centers across european countries (and us sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels. some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).


Eligibility criteria:
inclusion criteria: * diagnosis of ms according to mcdonald criteria * a treatment goal to maintain or improve upper limb function * no relapse within the last month * no changes in disease modifying medication and no corticoid-therapy within the last month * receive at least 10 sessions of physical or occupational therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months exclusion criteria: * other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, ...) * other neurological impairments with permanent damage (stroke, parkinson, ...) * ms-like syndromes such as neuromyelitis optica * not able to understand and execute simple instructions
physiotherapy of the pelvic floor in women with deep infiltrating endometriosis

Conditions: Endometriosis

Summary: the aim of our study is to evaluate the impact of pelvic floor physiotherapy in symptomatic patients affected by deep infiltrating endometriosis, using 3d/4d transperineal ultrasound for evaluation of pelvic floor morphometry, nrs (numerical rating scale) for evaluation of symptoms and validated questionnaires investigating intestinal, sexual and urinary functions. these results will be compared with those obtained from symptomatic patients affected by deep infiltrating endometriosis following the standard care procedure that does not provide pelvic floor physiotherapy.

symptomatic, nulliparous women with deep infiltrating endometriosis are included in the study. during the first medical examination, endometriosis related symptoms are assessed using nrs (numerical rating scale); intestinal, sexual and urinary functions are evaluated with validated questionnaires (knowles-eccersley-scott-symptom questionnaire (kess), female sexual function index (fsfi), bristol female lower urinary tract symptoms (bfluts)); pelvic floor morphometry at rest, during pelvic floor contraction and during valsalva manoeuvre is evaluated using 3d/4d transperineal ultrasound through the assessment of the levator hiatus area (lha). gynaecological examination, transvaginal and transabdominal ultrasound are performed. after the first medical examination, enrolled patients are randomized into two groups: patients in group a receive standard care procedure and pelvic floor physiotherapy; patients in group b receive standard care procedure only. pelvic floor physiotherapy protocol consists of six sessions (weeks 1, 3, 5, 8, 11 from the randomization). after four months from the first medical examination, endometriosis related symptoms, intestinal, sexual and urinary functions and pelvic floor morphometry are reassessed for all patients, using the same procedures, comparing the two groups and evaluating the impact of pelvic floor physiotherapy.

Eligibility criteria:
inclusion criteria: * patients with clinical and ultrasound diagnosis of deep endometriosis with related symptoms (chronic pelvic pain, dysmenorrhea, dyschezia, dyspareunia, dysuria) * nulliparity * obtaining informed consent exclusion criteria: * patients with an oncological disease or needing surgery for malignant pathologies * urogenital prolapse * history of surgery for deep infiltrating endometriosis * congenital or acquired malformations of pelvis and pelvic floor * history of diseases characterised by chronic pelvic pain (interstitial cystitis, irritable bowel disease, chronic vulvodynia).
a study to assess the efficacy and safety of mstt1041a in participants with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study will assess the efficacy and safety of mstt1041a (astegolimab) in participants with moderate to severe atopic dermatitis (ad). the study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period.


Eligibility criteria:
inclusion criteria * ability to comply with the study protocol * chronic ad that has been present for at least 3 years before the screening visit * documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications (medications or treatments applied directly to part of the body) or for whom topical treatments are otherwise medically inadvisable exclusion criteria * prior treatment with mstt1041a * treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives whichever is longer, before screening * treatment with any cell-depleting agents within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer * treatment with other biologics within 3 months or 5 half-lives before screening, whichever is longer * comorbid conditions that may interfere with evaluation of investigational medicinal product * history or evidence of substance abuse that would pose a risk to participant safety, interfere with the conduct of the study, have an impact on the study results, or affect the participant's ability to participate in the study * history of anaphylaxis, hypersensitivity to a biologic agent, or known hypersensitivity to any component of the mstt1041a or placebo injection * planned surgical intervention during the course of the study * pregnant or breastfeeding, or intending to become pregnant during the study * participant who is a member of the investigational team or his/her immediate family
the effect of conservative treatment on perceptual and cognitive asymmetry in scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: adolescent idiopathic scoliosis (ais) patients have been found to exhibit cortical asymmetry. this study aimed to examine the impact of conservative treatments on perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in ais patients with thoracic major curves.

background: adolescent idiopathic scoliosis (ais) patients have been found to exhibit cortical asymmetry. this study aimed to examine the impact of conservative treatments on perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in ais patients with thoracic major curves. method: this study involved 30 ais patients and 21 healthy subjects. the intervention group used a cheneau brace and performed 18 schroth best practice (sbp) exercise sessions. auditory lateralization was assessed using the dichotic listening paradigm (dlp) in both groups before and after the intervention.

Eligibility criteria:
inclusion criteria for intervention group: * having been diagnosed with ais, * being 10-16 years of age, * having a cobb angle of between 20° and 50° * risser's sign of 0-3, * having right thoracic scoliosis, * being right-handed, * having received no previous treatment that may affect scoliosis, * having no chronic disease requiring the use of medication. inclusion criteria for intervention group: * participants aged 10-16 years exclusion criteria for both groups: * having previous spinal operations, * hearing loss, or the presence of other muscular, neurological, or rheumatic diseases.
a study to compare sb16 (proposed denosumab biosimilar) to prolia® in postmenopausal women with osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: this is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, pk, pd, and immunogenicity of sb16 compared to prolia® in postmenopausal women with osteoporosis.

subjects will be randomised in a 1:1 ratio to receive either sb16 or prolia®. at month 12, subjects in prolia® treatment group will be randomised again in a 1:1 ratio to either continue on prolia® treatment or be transitioned to sb16 treatment. investigational product (60 mg in 1 ml of sb16 or prolia®) will be given subcutaneously every 6 months up to month 12, and the last assessment will be done at month 18.

Eligibility criteria:
inclusion criteria: * postmenopausal women who are 55 to 80 years of age at screening * ambulatory and visually unimpaired to participate in the study at screening, in the opinion of the investigator * absolute bmd consistent with t-score at the total hip or lumbar spine of -4 and -2.5 at screening * at least three evaluable vertebrae within l1 to l4, one evaluable femoral neck, and one evaluable hip joint for bmd measurement at screening * biologic naïve at screening * body weight of 50 kg and 90 kg at screening exclusion criteria: * one severe or more than two moderate vertebral fractures on spinal x-ray according to genant classification at screening * history of hip fracture or bilateral hip replacement at screening * uncorrected vitamin d deficiency at screening * hypercalcemia or hypocalcaemia at screening * inadequate haematological function at screening * inadequate renal or hepatic function at screening * known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the ip, including latex allergy or hereditary problems of fructose intolerance at screening * may not tolerate long-term calcium or vitamin d supplementation or subject with malabsorption of calcium or vitamin d supplements, in the opinion of the investigator, at screening * use of any of the medications that can affect bmd * use of any non-biologic ip that is not indicated for osteoporosis from another study or use of an investigational device at screening * non-osteoporosis medical conditions that can affect bmd at screening * any clinically significant disease or disorder or laboratory abnormality which, in the opinion of the investigator, would prevent the subject from completing the study or the interpretation of the study results at screening and randomisation
intermountain healthcare's enhanced recovery protocol for colon surgery with and without alvimopan use

Conditions: Ileus

Summary: the purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. the care process model is a combination of optimal iv fluid management, early feeding, early ambulation, patient education, and pain management.

narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal tract but does not compromise central nervous system-mediated opioid-based analgesia. length of stay is an important surrogate measure of quality after colon surgery and the most common reason for prolonged length of stay after abdominal surgery is delayed gastrointestinal recovery (postoperative ileus). the food and drug administration has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. in the 5 phase iii alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery care process model that is used by intermountain healthcare. in the most recently completed alvimopan phase iii trial, the mean postoperative length of stay was 5.2 days whereas the mean length of stay at intermountain healthcare is 4.4 days without the addition of alvimopan to the multidisciplinary colon care process model. this trial will investigate if the addition of alvimopan to the intermountain healthcare multidisciplinary care process can decrease length of stay compared with the multidisciplinary care process plus placebo.

Eligibility criteria:
inclusion criteria: 1. age \> 18 2. patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs 3. elective colon/rectal resection with anastomosis as primary procedure 4. patient enrolled in multidisciplinary colon care process exclusion criteria: 1. pregnancy or lactation 2. chronic opioid use or \> 3 doses in 7 days prior to surgery 3. history of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome 4. complete bowel obstruction 5. patients with end-stage renal disease as defined by the need for dialysis and the commonly accepted threshold for dialysis is a glomerular filtration rate of \< 15. 6. patients with severe hepatic impairment (childs-pugh class c) 7. asa 4 or 5 (asa 4 s incapacitating systemic disease that is a constant threat to life) 8. non-english speaking patients

Keywords: ileus post operative ileus
study the effect of oral zinc supplementation on enzymes of nitric oxide pathway

Conditions: Asthenozoospermia

Summary: the ability of spermatozoa to produce reactive oxygen species (ros) has been respected since the 1940's. oxidative stress limits the functional competence of mammalian spermatozoa via lipid peroxidation, the induction of oxidative dna damage and the formation of protein adducts. nitric oxide (no) is a free radical generated from the oxidation of l-arginine to l-citrulline by reduced nicotinamide adenine dinucleotide phosphate (nadph)-dependent no synthases. several studies suggest that the overproduction of this free radical and the subsequent excessive exposure to oxidative conditions have a potential pathogenetic implication, which due to the reduction of sperm motility. the present study was conducted to study the effect of zn supplementation on the levels of no synthase and arginase in semen of patients with asthenozoospmia.

previous studies suggest that high concentrations of no play an injurious consequence on spermatozoa kinetic characteristics. these studies reported that no may react with superoxide or hydrogen peroxide, resulting in the production of peroxinitrite, hydroxyl radical, or singlet oxygen, which cause oxidation of sperm membrane lipids and thiol proteins. no also may inhibit cellular respiration by nitro-sylation of heme in mitochondrial enzymes, aconitase, and glyceraldehyde phosphate dehydrogenase, leading to a reduction of adenosine triphosphate and that is due to loss of motility of spermatozoa.

Eligibility criteria:
inclusion criteria: * the presence of asthenozoospermia in the semen sample. exclusion criteria: * the absence of endocrinopathy, * varicocele, and * female factor infertility. smokers and alcoholic men were excluded from the study because of their recognized high seminal ros levels and decreased antioxidant levels
cellular immune responses in the liver in chronic hepatitis c (chc) patients

Conditions: Hepatitis C, Chronic; Liver Diseases; Virus Diseases

Summary: in order to persist in the liver, hcv has numerous nonspecific and specific strategies to overcome the immunity of the host. the crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. treatment with pegylated interferon alpha (ifnα) in combination with ribavirin (rbv) is the standard therapy for chronic hepatitis c is. the response to ifnα / rbv therapy depends on the effective cellular antiviral immune response in the liver. the understanding of the interaction between hcv and cellular immune response is important for the effective use of existing diagnostic techniques, the individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. in this study, the investigators want to investigate cellular immune responses in the liver of hcv infected patients and characterize the influence of these immune responses to the response to ifnα / rbv therapy.


Eligibility criteria:
inclusion criteria: * proven chronic hepatitis c * aged between 18 and 65 * willingness to give written informed consent to the study protocol exclusion criteria: * history of having received any ifn, peg-ifn or rbv * not eligible for antiviral treatment with peginterferon and ribavirin by standard of care

Keywords: hcv hepatitis c virus chc chronic hepatitis c interferon ribavirin hepatitis, viral, human anti-infective agents peginterferon alfa-2a peginterferon alfa-2b
efficacy of topical antioxidants in tretment of photoaging

Conditions: Photoaging

Summary: this randomized controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin.

•sample size calculation: the sample size was assessed prospectively using openepi version 3.01 to provide a 80% power to detect a 40-50% difference before and after treatment using either topical antioxidants or retinoids with a significance level of 0.05 (based on the results of a previous clinical trial). assuming 10% dropout, 30 patients will be recruited in each treatment group. •statistical analysis: data will be collected and recorded on excel data sheet. data will be tested for normality. quantitative data will be represented as mean and standard deviation, or median and interquartile range. qualitative data will be presented as number and percentage. the relevant statistical method will be used for comparison. p value will be considered statistically significant if it is less than 0.05

Eligibility criteria:
inclusion criteria: * adult volunteers \< 50 years old * clinical and dermoscopic features of photoaging. exclusion criteria: * genodermatoses associated with photosensitivity. * treatment by medications affecting skin aging (eg, topical and systemic retinoids) in the last 6 months prior to enrollment. * any recent cosmetic procedures.

Keywords: topical antioxidants photoaged skin
prenatal education about reducing labor stress (pearls)

Conditions: Labor Pain; Tocophobia

Summary: the purpose of this small randomized controlled trial (rct) is to compare the impact of a brief (16 hour) 3rd trimester mindfulness-based childbirth education program, "mind in labor (mil): working with pain in childbirth," with a standard care/"treatment as usual" (tau) active control condition of standard hospital- and community-based childbirth education. the mil group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing and greater childbirth self-efficacy), less perceived pain in labor, less use of pain medication in labor, greater birth satisfaction, and better prenatal and postpartum psychological adjustment compared to the tau group.


Eligibility criteria:
inclusion criteria: * age 18 or over * no prior full-term pregnancy or live birth prior to the current pregnancy * in 3rd trimester of healthy, singleton pregnancy * willingness to be randomized * able to read, write, and understand spoken english * planned hospital birth in the san francisco bay area exclusion criteria: * current or prior formal meditation experience * formal yoga practice prior to pregnancy (brief prenatal yoga practice will not lead to exclusion) * participation in other mind/body childbirth preparation course (e.g., with hypnosis focus) * planned elective cesarean birth * planned homebirth or other non-hospital birth setting

Keywords: childbirth mindfulness fear of labor labor pain coping self-efficacy childbirth satisfaction depression
combining radiotherapy and temozolomide with dichloroacetate in patients with newly diagnosed glioblastoma

Conditions: Glioblastoma

Summary: this is a study to see whether radiotherapy plus chemotherapy (temozolomide) plus dichloroacetate (dca) improves overall survival and offers better control of the disease in patients with newly diagnosed glioblastoma multiforme tumours.

patients with newly diagnosed glioblastoma multiforme tumours, once consented to the study, would undergo standard treatment of radiotherapy plus chemotherapy (tmz) with dca in pill form (twice a day) during the radiation phase of the study and then with tmz for six months after. other elements of the clinical trial include pharmacokinetics and mgmt genetic testing.

Eligibility criteria:
inclusion criteria: * newly diagnosed gbm * diagnosis must be established by open biopsy or tumour resection * tumour must have a supratentorial component * over 18 years * pre-treatment evaluations must be met * study therapy to begin within 6 weeks of surgery * kps greater or equal to 70 * patients must sign informed consent * if female, patients must not be pregnant or lactating * women of childbearing potential and male participants must practice adequate contraception exclusion criteria: * prior invasive malignancy )except for non-melanomatous skin cancer) unless disease free for greater than 3 years * recurrent or multifocal malignant gliomas * metastatic disease of leptomeningeal spread * prior chemo or radiosensitizers for cancers of the head and neck region * prior rt to head and neck region except for t1 glottic cancer, resulting in overlap of radiation fields. * severe active co-morbidity define in protocol * pregnant of lactating women * women of childbearing potential or men who are sexually active who are not willing or able to use medically acceptable forms of contraception; this exclusion is necessary due to the treatment involved potentially being teratogenic. * prior allergic reaction to temozolomide and/or dichloroacetate * history of hiv/aids

Keywords: radiotherapy plus temozolomide plus dca pk profile of dca mgmt promoter methylation status newly diagnosed glioblastoma multiform tumours